Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
The Executive Director, Regulatory CMC leads an integrated group of regulatory CMC professionals, owns the regulatory CMC product portfolio strategy and is a member of the Regulatory Affairs Leadership Team. You will partner with functional heads of Technical Operations, Quality and Regulatory (e.g. Strategy, Operations & International) to ensure creation and timely delivery of science-based Quality documentation for Rhythm’s portfolio from development through post-approval.
You will serve as GRA’s senior strategic leader for regulatory CMC, providing enterprise-level leadership across the portfolio and guiding science-based, pragmatic Regulatory CMC strategies and risk-based decisions. Within and external to Rhythm, you will be a developing thought leader, building Rhythm’s presence within the broader regulatory CMC and Quality communities and advancing Rhythm’s priorities within the global regulatory environment. You will focus on team evolution by setting the tone for the group’s culture, developing talent and leadership capability, and ensuring the function continues to evolve with Rhythm’s portfolio and business needs.
Responsibilities and Duties Lead the Regulatory CMC function, setting priorities and providing strategic oversight across the portfolio, including regulatory strategy, risk assessment, optionality and outcomes. Provide appropriate senior-level review and approval of regulatory CMC documentation aligned with process.
Represent Regulatory CMC in appropriate governance forums, bringing forward applicable considerations, risk assessment/mitigation, recommendations and influencing cross-functional portfolio decisions.
Translate Rhythm’s corporate, portfolio, and patient priorities into clear Regulatory CMC priorities, build broader business acumen across the team and ensure the patient perspective is incorporated.
Build and sustain network with key internal and external stakeholders, contributing to regulatory landscape assessments and advocating for Rhythm’s priorities with health authorities and/or industry associations.
Anticipate and interpret changes within the global regulatory CMC / Quality environment, with a focus on ICH related markets, and advise internal stakeholders on potential portfolio impact, risks, and recommended actions.
Provide senior Regulatory CMC leadership for key global health authority interactions, participating directly as needed, preparing team members for these engagements and ensuring consistent Regulatory CMC positions across the portfolio.
Build and develop a high-performing Regulatory CMC team by setting clear expectations, coaching and developing talent, providing actionable feedback, and creating opportunities for team members to expand their leadership and strategic capabilities, aligned with Rhythm’s Values and Global Regulatory Affairs leadership principles.
Set a forward-looking vision for the function, including the thoughtful adoption of automation, AI, and new ways of working to improve efficiency, elevate strategic contribution, and evolve team capabilities to meet business needs.
Own functional resource planning, budget management, capability planning, and ensure appropriate processes, standards, training, and ways of working are in place to support the portfolio.
Partner with Regulatory, Technical Operations, Quality, and other senior leaders to evaluate…